Vacancy expired!
- Competitive Salary!
- Great Benefits Package!
- The Opportunity to Join an Amazing Team!
- Bachelor's degree - Master's degree a plus but not required.
- 5+ years of progressive quality and regulatory affairs experience in an FDA regulated drug and/or medical device environment, preferably including some experience with combination products.
- Experience with Combination Products is strongly preferred and a big plus
- Track record of success, and a broad understanding of current QA practices as they apply to product development, manufacturing and commercial operations in an FDA regulated and ISO certified environment.
- Advanced understanding of QA and Regulatory Affairs requirements, specifically knowledge of current FDA guidelines (experience with other Agencies a plus)
- Experience applying quality risk management for medical device and/or drug product development and manufacturing.
- Experience in GMP and other Regulatory compliance requirements.
- Experienced in regulatory filings for US (EU and other key countries/regions a plus).
- Excellent written and verbal communication skills.
- Able to balance QA responsibilities while working in a startup (i.e., less structured) environment
Vacancy expired!